ArticleCancer chemotherapy and pharmacology2008
Phase I trial of weekly trabectedin (ET-743) and gemcitabine in patients with advanced solid tumors.
Article in Cancer chemotherapy and pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed.
- A phase I safety and efficacy clinical trial of plocabulin and gemcitabine in patients with advanced solid tumors.Investigational new drugs · 2024Article
- Trabectedin-Related Heart Failure: Case Report and a Systematic Review of the Literature.Frontiers in oncology · 2021Review
- Starvation tactics using natural compounds for advanced cancers: pharmacodynamics, clinical efficacy, and predictive biomarkers.Cancer medicine · 2018Review
- Phase I clinical and pharmacokinetic study of PM01183 (a tetrahydroisoquinoline, Lurbinectedin) in combination with gemcitabine in patients with advanced solid tumors.Investigational new drugs · 2017Article
- Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives.Advances in therapy · 2016Review
- Pharmacodynamic modeling of combined chemotherapeutic effects predicts synergistic activity of gemcitabine and trabectedin in pancreatic cancer cells.Cancer chemotherapy and pharmacology · 2016Article
- Phase I study of the safety and pharmacokinetics of trabectedin with docetaxel in patients with advanced malignancies.Cancer chemotherapy and pharmacology · 2015Article
- Trabectedin in soft tissue sarcomas.Marine drugs · 2015Review
- Article
- Trabectedin: novel insights in the treatment of advanced sarcoma.Current oncology reports · 2014Review
- Clinical utility of trabectedin for the treatment of ovarian cancer: current evidence.OncoTargets and therapy · 2014Review
- Phase I combination study of trabectedin and capecitabine in patients with advanced malignancies.Investigational new drugs · 2012Article
- Trabectedin: safety and efficacy in the treatment of advanced sarcoma.Clinical Medicine Insights. Oncology · 2011Article
- New developments in treatment of ovarian carcinoma: focus on trabectedin.Cancer management and research · 2010Article
- Trabectedin: the evidence for its place in therapy in the treatment of soft tissue sarcoma.Core evidence · 2010Article
- Review
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
purposeTo determine the maximum tolerated dose (MTD) of trabectedin plus gemcitabine administered on a weekly schedule in patients with advanced solid tumors.
methodsPatients with ECOG performance status 0-1 and adequate organ function were enrolled. On days 1, 8, and 15 of a 28-day cycle, patients received gemcitabine (starting dose, 800 mg/m(2)) followed by trabectedin (starting dose, 0.3 mg/m(2)). Strict liver function test treatment criteria were employed to avoid hepatic toxicity seen in previous trabectedin studies. Plasma samples were collected during cycles 1 and 2 for pharmacokinetic analyses.
resultsFifteen patients received >or=1 dose, with a median of two treatment cycles (range 1-10). The most common drug-related toxicity was hepatic. Dose reductions were required for trabectedin in four (27%) patients and gemcitabine in six (40%) patients. Cycle delays/dose holds were required in 11 (73%) patients and doses above trabectedin 0.4 mg/m(2) and gemcitabine 1,000 mg/m(2), which is the recommended phase II dose, were not feasible. Seven patients maintained stable disease after two cycles. Gemcitabine and trabectedin pharmacokinetics were not altered substantially with concomitant administration.
conclusionsGiven the lack of pharmacokinetic interaction and potential efficacy of trabectedin and gemcitabine combination therapy, further study is warranted with alternate schedules.
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